The European Commission (EC) has approved Otsuka Pharmaceutical and Lundbeck’s atypical oral antipsychotic Rxulti (brexpiprazole) for schizophrenia in adolescents aged 13 years and above.
Schizophrenia is a progressive mental illness marked by disordered cognition.
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The decision expands the drug’s indication, which was previously approved for adult schizophrenia treatment within the European Union (EU) in 2018.
The EC’s latest decision is supported by a randomised, six-week, double-blind, active-referenced and placebo-controlled trial involving 316 adolescent subjects.
The study aimed to assess the safety and efficacy of the drug, with the primary outcome focusing on safety and the secondary on efficacy.
Lundbeck research and development head and executive vice-president Johan Luthman said: “Today marks a major milestone for young patients, caregivers and families navigating the complexities of schizophrenia.
“This approval is a testament to our commitment and unwavering support to lessen the disease burden for patients and caregivers in the EU, by providing a treatment option with proven efficacy and tolerability.”
Subjects of the given age group who received the drug, at dosages between two and four milligrams per day, experienced a significant decrease in the severity of their symptoms.
These improvements were measured using the Positive and Negative Syndrome Scale (PANSS) total score against a placebo.
The therapy was generally well-tolerated, exhibiting a safety profile consistent with that observed in adults with schizophrenia.
Brexpiprazole is administered once daily and was discovered by Otsuka. It is being jointly developed and commercialised through a partnership and licence agreement between Lundbeck and Otsuka Pharmaceutical Europe.
Otsuka Pharmaceutical Europe CEO Andy Hodge stated: “The prognosis for adolescence-onset schizophrenia is poor compared with adult-onset schizophrenia and can be associated with more chronic and severe symptoms.”
